PITAVASTATIN TECNIGEN 1 mg FILM-COATED TABLETS

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1. What Pitavastatin TecniGen is and what it is used for
2. What you need to know before taking Pitavastatin TecniGen
3. How to take Pitavastatin TecniGen
4. Possible side effects
5. Storage of Pitavastatin TecniGen
6. Contents of the pack and additional information

1. What Pitavastatin TecniGen is and what it is used for

This medicine contains a substance called pitavastatin. It belongs to a group of medicines called

‘statins’. Pitavastatin is used to correct blood lipid levels and can be taken by children from 6 years of age and adults. An imbalance of fats, especially cholesterol, can sometimes cause a heart attack or stroke.

You have been prescribed pitavastatin because you have an imbalance of fats, and changes in your diet and lifestyle have not been sufficient to correct it. You should continue with a low-cholesterol diet and lifestyle changes while taking pitavastatin.

2. What you need to know before taking Pitavastatin TecniGen

Do not take pitavastatin:

• if you are allergic (hypersensitive) to pitavastatin, to any other statin, or to any of the other

components of pitavastatin (see section 6. ‘Contents of the pack and additional information’).

• if you are pregnant or breastfeeding.
• if you are a woman who can become pregnant and are not using an effective contraceptive method (see ‘Pregnancy and breastfeeding’).
• if you currently have liver problems.
• if you are taking ciclosporin, a medicine used after organ transplantation.
• if you have repeated or unexplained muscle pain.

If you have any doubts, consult your doctor or pharmacist before starting to take pitavastatin.

Warnings and precautions

Consult your doctor or pharmacist before starting to take pitavastatin:

• if you have severe respiratory failure (severe breathing problems).
• if you have ever had kidney problems.
• if you have ever had liver problems. ‘Statins’ can affect the liver in some people. Your doctor will usually perform blood tests (to see how your liver is working) before and during treatment with pitavastatin.
• if you have ever had thyroid problems.
• if you or a family member have a history of muscle problems.
• if you have previously had muscle problems when taking other cholesterol-lowering medicines (e.g., statins or fibrates).
• if you drink a lot of alcohol.
• if you are taking or have taken in the last 7 days a medicine that contains fusidic acid (used to treat bacterial infections) orally or by injection. The combination of fusidic acid and pitavastatin can cause serious muscle problems (rhabdomyolysis).
• if you have or have had myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing) or ocular myasthenia (a disease that causes weakness of the eye muscles), as statins can sometimes worsen the disease or cause myasthenia (see section 4).

If any of the above applies to you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin. Also, inform your doctor or pharmacist if you experience constant muscle weakness. Additional tests and medication may be necessary to diagnose and treat this problem.

While you are taking this medicine, your doctor will check if you have diabetes or are at risk of developing diabetes. This risk of diabetes increases if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure.

Children and adolescents

Pitavastatin should not be given to children under 6 years of age.

Before taking pitavastatin, adolescent girls should receive guidance and counseling on contraceptives

Other medicines and Pitavastatin TecniGen

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those obtained without a prescription or herbal products. Some medicines can interfere with the way others work.

In particular, tell your doctor or pharmacist if you are taking any of the following medicines:

• other medicines called ‘fibrates’, such as gemfibrozil and fenofibrate.
• erythromycin or rifampicin, antibiotics used for infections.
• warfarin or any other medicine used to thin the blood.

Medicines for HIV called ‘protease inhibitors’ (e.g., ritonavir, lopinavir, darunavir, atazanavir) and ‘non-nucleoside reverse transcriptase inhibitors’ (e.g., efavirenz).

• niacin (vitamin B3).
• If you need to take oral fusidic acid to treat a bacterial infection, you will need to stop using this medicine. Your doctor will tell you when you can restart treatment with pitavastatin. The use of pitavastatin with fusidic acid can cause muscle weakness, sensitivity, or pain (rhabdomyolysis). For more information on rhabdomyolysis, see section 4.

If any of the above applies to you (or you have any doubts), consult your doctor or pharmacist before starting to take pitavastatin.

Taking pitavastatin with food and drinks

You can take pitavastatin with or without food.

Pregnancy, breastfeeding, and fertility

Do not take pitavastatin if you are pregnant or breastfeeding. If you want to become pregnant, inform your doctor before starting to take pitavastatin.

If you are a woman who can become pregnant, you must use an effective contraceptive method while taking pitavastatin. If you become pregnant while taking pitavastatin, stop taking pitavastatin and consult your doctor immediately.

If you are pregnant or breastfeeding, consult your doctor or pharmacist before taking any medicine.

Driving and using machines

Pitavastatin is not expected to affect your ability to drive or use machines. However, if you feel dizzy or drowsy while taking pitavastatin, do not drive or use machines or tools.

Pitavastatin TecniGen contains lactose

Pitavastatin contains lactose (a type of sugar). If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medicine.

3. How to take Pitavastatin TecniGen

Follow the instructions for administration of this medicine exactly as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist again.

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Swallow the tablet whole with water, with or without food. You can take it at any time of day. However, try to take the tablet at the same time every day.

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• To start, the usual dose is 1 mg once a day. After a few weeks, your doctor may decide to increase the dose. The maximum dose in adults and children over 10 years is 4 mg per day.
• If you have liver problems, you should not take more than 2 mg per day.

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• The maximum dose in children under 10 years is 2 mg per day.
• If necessary, the tablets can be dispersed in a glass of water just before taking; then rinse the glass with more water and drink immediately. Do not use fruit juices or milk to disperse the tablets.
• Pitavastatin is not recommended for use in children under 6 years of age.

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• If you go to the hospital or receive treatment for another problem, inform the medical staff that you are taking pitavastatin.
• Your doctor may perform regular cholesterol tests.
• Do not stop taking pitavastatin without talking to your doctor first. Your cholesterol levels may increase.

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If you take more pitavastatin than you should, inform your doctor or go to the hospital immediately. Bring the medicine package with you.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine and the amount taken.

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Do not worry, take the next dose at the correct time. Do not take a double dose to make up for missed doses.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them. This medicine can cause the following side effects:

Stop taking Pitavastatin TecniGen and consult your doctor immediately if you notice any of the following serious side effects, as you may need urgent medical treatment:

• Allergic reaction: some signs are difficulty breathing, swelling of the face, lips, tongue, or throat, swallowing problems, intense itching of the skin (with hives).
• Unexplained muscle pain or weakness, especially if you are not feeling well, have a fever, or if your urine is brownish-red. In rare cases (less than 1 person in 1,000), pitavastatin can cause unpleasant muscle effects. If these effects are not investigated, they can cause serious problems such as abnormal muscle breakdown (rhabdomyolysis), which can lead to kidney problems.
• Respiratory problems, including persistent cough and/or difficulty breathing or fever.
• Liver problems that can cause yellowing of the skin and eyes (jaundice).
• Pancreatitis (severe abdominal and back pain). Other side effects include:

Common (affect less than 1 person in 10)

• joint pain, muscle pain
• constipation, diarrhea, indigestion, nausea
• headache

Uncommon (affect less than 1 person in 100)

• muscle spasms
• weakness, fatigue, or malaise
• swelling of the ankles, feet, or fingers
• stomach pain, dry mouth, vomiting, loss of appetite, altered taste
• pallor and weakness or shortness of breath (anemia)
• itching or skin rash
• ringing in the ears
• dizziness or drowsiness, insomnia (or other sleep disorders, including nightmares)
• increased need to urinate (urinary frequency)
• numbness and reduced sensitivity in the fingers and toes, legs, and face

Rare (affect less than 1 person in 1,000)

• redness of the skin, hives, and itching
• vision loss
• tongue pain
• unpleasant sensation or discomfort in the stomach
• breast enlargement in men (gynecomastia)

Side effects of unknown frequency

• Constant muscle weakness.
• Lupus-like syndrome (with rash, joint disorders, and effects on blood cells)
• Severe myasthenia (a disease that causes generalized muscle weakness that can affect the muscles used for breathing).
• Ocular myasthenia (a disease that causes weakness of the eye muscles).

Consult your doctor if you experience weakness in your arms or legs that worsens after periods of activity, double vision, or drooping eyelids, difficulty swallowing, or difficulty breathing.

Other possible side effects

• Memory loss
• Sexual dysfunction
• Depression
• Diabetes. This is more likely if you have high sugar and fat levels in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Pitavastatin TecniGen

This medicine does not require special storage conditions.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date shown on the blister pack and carton after EXP. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Return the packaging and any unused medicine to the pharmacy. If you have any doubts, ask your pharmacist how to dispose of the packaging and unused medicine. This will help protect the environment.

6. Contents of the pack and additional information

Composition of Pitavastatin TecniGen

The active substance is pitavastatin.

Pitavastatin TecniGen 1 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 1 mg of pitavastatin.

Pitavastatin TecniGen 2 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 2 mg of pitavastatin.

Pitavastatin TecniGen 4 mg: Each film-coated tablet contains pitavastatin calcium equivalent to 4 mg of pitavastatin.

The other ingredients are: lactose monohydrate, povidone, low-substituted hydroxypropylcellulose, calcium carbonate, magnesium stearate, hypromellose (E464), titanium dioxide (E171), triacetin.

Appearance of the product and contents of the pack

Pitavastatin TecniGen 1 mg: The film-coated tablets are round, biconvex, white to off-white, with a score line on one side and a diameter of approximately 6 mm. The score line should not be used to divide the tablet.

Pitavastatin TecniGen 2 mg: The film-coated tablets are round, biconvex, white to off-white, and have a diameter of approximately 7 mm.

Pitavastatin TecniGen 4 mg: The film-coated tablets are round, biconvex, white to off-white, with a score line on one side and a diameter of approximately 9.5 mm. The score line should not be used to divide the tablet.

It is presented in blister packs containing 28 film-coated tablets.

Marketing authorization holder and manufacturer

Marketing authorization holder:

Tecnimede España Industria Farmacéutica, S.A.

Avda. de Bruselas, 13, 3º D. Edificio América. Polígono Arroyo de la Vega,

28108 Alcobendas (Madrid)

Spain

Manufacturer:

Laboratorios Alter S.A.

C/ Mateo Inurria 30

28036 Madrid

Spain

Date of the last revision of this leaflet: March 2023

Other sources of information

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/